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出境医 / 临床实验 / Investigation of Milk Peptides on Postprandial Blood Glucose Profile
Investigation of Milk Peptides on Postprandial Blood Glucose Profile
Study Description
Brief Summary:
Aim of the study is to investigate the effect of two different dosages of milk peptides on postprandial blood glucose profile in prediabetic subjects compared to placebo. This will be investigated in a cross-over double blind randomized placebo controlled study design. Additionally, long term effects on glucose status, insulin sensitivity and postprandial blood glucose profile will be investigated in a follow up 6-week open label phase with the low dose only.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Postprandial Hyperglycemia | Dietary Supplement: Low dose milk peptide Dietary Supplement: High Dose milk peptide Dietary Supplement: Placebo | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 21 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Intervention Model Description: | double blind cross over and open for the phase II of the study |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | first phase of the study is RCT double blind placebo cross-over. The second phase is open during 6 weeks of supplementation |
| Primary Purpose: | Prevention |
| Official Title: | Investigation of Milk Peptides on Postprandial Blood Glucose Profile: Randomized, Double-blind, Placebo-controlled, Cross-over Study With Different Dosages Followed by an Open-label Single Arm Phase to Estimate Long Term Effects |
| Actual Study Start Date : | September 26, 2018 |
| Actual Primary Completion Date : | February 20, 2019 |
| Actual Study Completion Date : | April 30, 2019 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: High dose Milk peptides
2800mg of whey protein hydrolysates single dose
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Dietary Supplement: High Dose milk peptide
what is the effect of milk peptides 2800mg on postprandial glycemia after a meal rich in carbohydrates (75g)
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Active Comparator: Low dose Milk peptides
1400mg of whey protein hydrolysate Single dose and 6 weeks intervention
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Dietary Supplement: Low dose milk peptide
what is the effect of milk peptides 1400mg on postprandial glycemia after a meal rich in carbohydrates (75g)
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Placebo Comparator: Placebo
maltodextrin
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Dietary Supplement: Placebo
what is the effect of placebo on postprandial glycemia after a meal rich in carbohydrates (75g)
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Outcome Measures
Primary Outcome Measures :
- Glucose-iAUC(0-180min) [ Time Frame: day 1, day 8, day 15, day 57 ]Area under the curve calculated as the incremental area under the blood glucose response curve, ignoring the area beneath the fasting concentration
Secondary Outcome Measures :
- Cmax [ Time Frame: day 1, day 8, day 15, day 57 ]Maximum blood glucose concentration
- Max-Increase [ Time Frame: day 1, day 8, day 15, day 57 ]Cmax minus baseline value
- Tmax [ Time Frame: day 1, day 8, day 15, day 57 ]Time to reach maximum blood glucose concentration
- Tbaseline [ Time Frame: day 1, day 8, day 15, day 57 ]First time to reach baseline again after increase or decrease in blood glucose
- AUC(0-180min): [ Time Frame: day 1, day 8, day 15, day 57 ]Total area under curve from 0 to 180 min for blood glucose concentration
- Insulin-iAUC(0-180min) [ Time Frame: day 1, day 8, day 15, day 57 ]Area under the curve calculated as the incremental area under the Insulin response curve, ignoring the area beneath the fasting concentration
- Cmax Baseline Insulin Max_increase Insulin [ Time Frame: day 1, day 8, day 15, day 57 ]Max_increase Insulin Cmax minus baseline insulin value
- Tmax insulin [ Time Frame: day 1, day 8, day 15, day 57 ]time to reach maximum Insulin concentration
- Fasting glucose, fasting insulin [ Time Frame: Baseline and Day 57 ]
- HOMA index [ Time Frame: Baseline and Day 57 ]Parameters of insulin sensitivity:
- HbA1c level [ Time Frame: Baseline (V5) and Day 57 (after 6 weeks) ]HbA1c level after 6 weeks of supplementation
- Matsuda index [ Time Frame: Baseline and Day 57 ]Insulin sensitivity
- Quicki Index [ Time Frame: Baseline and Day 57 ]Insulin sensitivity
Eligibility Criteria
| Ages Eligible for Study: | 30 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Male and female subjects with prediabetic HbA1c values between 5.7% - 6.4% and/or Fasting blood glucose ≥ 5.6 mmol/l (≥ 100 mg/dl) und < 7.0 mmol/l (< 125 mg/dl) (in venous plasma)
- Age: 30-70 years
- Body mass index 19-35 kg/m2
- Non-smoker
- Caucasian
- Availability and presence in the study unit for approx. 3.5 hours/ week for 3 times in a row with approx. 1 week of washout in between.
- Signed informed consent form
- No changes in food habits or physical activity 3 months prior to screening and during the study
Exclusion Criteria:
- Presence of disease or drug(s) influencing digestion and absorption of nutrients or bowel habits
- Intake of medications known to affect glucose tolerance, e.g., diabetic medication, steroids, protease inhibitors or antipsychotics
- Diagnosed Typ 2-Diabetics with medical treatment
- Chronic intake of substances affecting blood coagulation (e.g. acetylic acid (100 mg as standard prophylactic treatment allowed when dose is stable 1 month prior to screening), anticoagulants, diuretics, thiazides (diuretics and thiazides allowed e.g. for hypertension treatment when dose is stable 1 month prior to screening)), which in the investigator's opinion would impact patient safety
- Severe liver, renal or cardiac disease
- Acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks
- Known inflammatory and malignant gastrointestinal diseases (i.e. colitis ulcerosa, Morbus Crohn, celiac disease, malignant diseases e.g. colon-cancer, rectum cancer, pancreatitis)
- Clinically relevant findings as established by medical history, physical examination, clinical laboratory and/or vital signs
- Major medical or surgical event requiring hospitalization within the previous 3 months
- Intake of antibiotics within 4 weeks before the test days
- Known alcohol abuse or drug abuse
- Pregnant or breast feeding women
- Known or suspected allergy to any component of the investigational product(s) (e.g. milk protein)
- Known HIV-infection
- Known acute or chronic hepatitis B and C infection
- Blood donation within 4 weeks prior to visit 1 or during the study
- Subject unable to co-operate adequately
- Participation in a clinical study with an investigational product within one month before start of study
Contacts and Locations
Locations
| Germany | |
| Biotesys | |
| Esslingen, Germany | |
Sponsors and Collaborators
Ingredia S.A.
Investigators
| Principal Investigator: | Audrey BOULIER, MD | Ingredia S.A. |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 24, 2019 | ||||
| First Posted Date ICMJE | May 1, 2019 | ||||
| Last Update Posted Date | May 14, 2019 | ||||
| Actual Study Start Date ICMJE | September 26, 2018 | ||||
| Actual Primary Completion Date | February 20, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Glucose-iAUC(0-180min) [ Time Frame: day 1, day 8, day 15, day 57 ] Area under the curve calculated as the incremental area under the blood glucose response curve, ignoring the area beneath the fasting concentration
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Investigation of Milk Peptides on Postprandial Blood Glucose Profile | ||||
| Official Title ICMJE | Investigation of Milk Peptides on Postprandial Blood Glucose Profile: Randomized, Double-blind, Placebo-controlled, Cross-over Study With Different Dosages Followed by an Open-label Single Arm Phase to Estimate Long Term Effects | ||||
| Brief Summary | Aim of the study is to investigate the effect of two different dosages of milk peptides on postprandial blood glucose profile in prediabetic subjects compared to placebo. This will be investigated in a cross-over double blind randomized placebo controlled study design. Additionally, long term effects on glucose status, insulin sensitivity and postprandial blood glucose profile will be investigated in a follow up 6-week open label phase with the low dose only. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Intervention Model Description: double blind cross over and open for the phase II of the study Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: first phase of the study is RCT double blind placebo cross-over. The second phase is open during 6 weeks of supplementation Primary Purpose: Prevention
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| Condition ICMJE | Postprandial Hyperglycemia | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
21 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | April 30, 2019 | ||||
| Actual Primary Completion Date | February 20, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 30 Years to 70 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Germany | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03932695 | ||||
| Other Study ID Numbers ICMJE | BTS1130/17 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Ingredia S.A. | ||||
| Study Sponsor ICMJE | Ingredia S.A. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Ingredia S.A. | ||||
| Verification Date | April 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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